Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

To assess TCI153 prebiotics product on skin condition improvement

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo sachet; Dietary supplement: TCI153 probiotic sachet

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan City, Taiwan, 71710
    • Chia Nan University of Pharmacy & Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults aged above 18 years old

Exclusion Criteria:

• Subject who is not willing to participate in this study.
• Patients with diseases of the skin, liver, kidney.
• Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
• Female who is pregnant or nursing or planning to become pregnant during the course of the study.
• Received facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 4 weeks.
• Constant drug use
• Students who are currently taking courses taught by the principal investigator of this trial.
• Subject who is not willing to have their photos published in public.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo sachet; consume 1 sachet per day	Dietary supplement: Placebo sachet; Consume 1 sachet daily
Experimental: TCI153 sachet; consume 1 sachet per day	Dietary supplement: TCI153 probiotic sachet; Consume 1 sachet daily; Other Names: Ligilactobacillus salivarius TCI153 sachet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 8 weeks
The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Change from Baseline skin texture at 8 weeks
The change of skin melanin index	Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units	Change from Baseline skin melanin index at 8 weeks
The change of skin L* value	Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100	Change from Baseline L* value at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin elasticity	Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 8 weeks
The change of skin erythema index	Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units	Change from Baseline skin erythema index at 8 weeks
The change of skin moisture	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Change from Baseline skin moisture at 8 weeks
The change of transepidermal water loss (TEWL)	Tewameter® TM 210 was utilized to measure TEWL. Units: g/hm²	Change from Baseline TEWL at 8 weeks
The change of skin pores	VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units	Change from Baseline AGEs at 8 weeks
The change of gut microbiome composition	Gut microbiome sequencing	Change from Baseline AGEs at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of liver function biomarkers (AST, ALT) of blood	Fasting venous blood was sampled to measure liver function biomarkers	Change from Baseline liver function biomarkers at 8 weeks
The change of renal function biomarkers (creatinine, BUN) of blood	Fasting venous blood was sampled to measure renal function biomarkers	Change from Baseline renal function biomarkers at 8 weeks
The change of fasting blood glucose	Fasting venous blood was sampled to measure blood glucose	Change from Baseline blood glucose at 8 weeks
The change of sialic acid	Fasting venous blood was sampled to measure sialic acid	Change from Baseline sialic acid at 8 weeks
The change of Epidermal Growth Factor (EGF)	Fasting venous blood was sampled to measure EGF	Change from Baseline EGF at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy & Science

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 23-091-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No